ID
28843
Description
Study ID: 100723 Clinical Study ID: AXR100723 Study Title: A 24 Week Randomized, Double-blind, Double-dummy, Multicenter Study to Compare the Efficacy of Formulation X and AVANDIA™ (8mg OD) in Subjects with Type 2 Diabetes Mellitus Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: rosiglitazone Trade Name: Avandia; Avandia XR; Avandia XR,Rosiglitazone XR,Avandia; Rosiglitazone XR Study Indication: Diabetes Mellitus, Type 2 Documentation part: Run-In - Visit 3
Keywords
Versions (2)
- 2/8/18 2/8/18 -
- 2/8/18 2/8/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
February 8, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Efficacy of Formulation X and AVANDIA in Subjects with Type 2 Diabetes Mellitus 100723
Screening - Visit 2
- StudyEvent: ODM
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Height
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1]
- C0005890
Description
Weight
Data type
float
Measurement units
- kg
Alias
- UMLS CUI [1]
- C0005910
Description
Blood Pressure - sitting, Systolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0871470
- UMLS CUI [1,2]
- C0277814
Description
Blood Pressure - sitting, Diastolic
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1,1]
- C0428883
- UMLS CUI [1,2]
- C0277814
Description
Heart Rate
Data type
integer
Measurement units
- beats/ min
Alias
- UMLS CUI [1]
- C0018810
Description
Cardiovascular Medical History
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0007222
Description
Myocardial infarction
Data type
integer
Alias
- UMLS CUI [1]
- C0027051
Description
Ischaemic heart disease without cardiomyopathy
Data type
integer
Alias
- UMLS CUI [1]
- C1869045
Description
Ischaemic heart disease with cardiomyopathy
Data type
integer
Alias
- UMLS CUI [1,1]
- C1869045
- UMLS CUI [1,2]
- C0878544
Description
Stable angina
Data type
integer
Alias
- UMLS CUI [1]
- C0340288
Description
Unstable angina
Data type
integer
Alias
- UMLS CUI [1]
- C0002965
Description
Atherosclerosis
Data type
integer
Alias
- UMLS CUI [1]
- C0004153
Description
Valvular heart disease
Data type
integer
Alias
- UMLS CUI [1]
- C0018824
Description
Peripheral vascular disease
Data type
integer
Alias
- UMLS CUI [1]
- C0085096
Description
Cerebrovascular disease
Data type
integer
Alias
- UMLS CUI [1]
- C0007820
Description
Transient ischaemic attack
Data type
integer
Alias
- UMLS CUI [1]
- C0007787
Description
Stroke
Data type
integer
Alias
- UMLS CUI [1]
- C0038454
Description
Cardiac arrest
Data type
integer
Alias
- UMLS CUI [1]
- C0018790
Description
Coronary artery disease
Data type
integer
Alias
- UMLS CUI [1]
- C1956346
Description
Heart failure (CHF and acute)
Data type
integer
Alias
- UMLS CUI [1]
- C0018801
Description
Arrhythmia
Data type
integer
Alias
- UMLS CUI [1]
- C0003811
Description
Left ventricular dysfunction
Data type
integer
Alias
- UMLS CUI [1]
- C0242698
Description
Pulmonary oedema
Data type
integer
Alias
- UMLS CUI [1]
- C0034063
Description
Hypertension
Data type
integer
Alias
- UMLS CUI [1]
- C0020538
Description
Oedema
Data type
integer
Alias
- UMLS CUI [1]
- C0013604
Description
Left ventricular hypertrophy
Data type
integer
Alias
- UMLS CUI [1]
- C0149721
Description
Cardiomegaly
Data type
integer
Alias
- UMLS CUI [1]
- C0018800
Description
Cardiomyopathy
Data type
integer
Alias
- UMLS CUI [1]
- C0878544
Description
Diastolic dysfunction
Data type
integer
Alias
- UMLS CUI [1]
- C0520863
Description
Coronary artery by-pass
Data type
integer
Alias
- UMLS CUI [1]
- C0010055
Description
Angioplasty
Data type
integer
Alias
- UMLS CUI [1]
- C0162577
Description
STENT insertion
Data type
integer
Alias
- UMLS CUI [1]
- C0398087
Description
Cardiac transplantation
Data type
integer
Alias
- UMLS CUI [1]
- C0018823
Description
Amputation
Data type
integer
Alias
- UMLS CUI [1]
- C0002688
Description
Pacemaker insertion
Data type
integer
Alias
- UMLS CUI [1]
- C0189843
Description
Carotid endarterectomy
Data type
integer
Alias
- UMLS CUI [1]
- C0014099
Description
Vascular bypass graft (other than coronary)
Data type
integer
Alias
- UMLS CUI [1]
- C0863745
Description
Diabetes Medical History
Alias
- UMLS CUI-1
- C0011849
- UMLS CUI-2
- C0262926
Description
Diabetic retinopathy
Data type
integer
Alias
- UMLS CUI [1]
- C0011884
Description
Autonomic neuropathy
Data type
integer
Alias
- UMLS CUI [1]
- C0259749
Description
Peripheral neuropathy
Data type
integer
Alias
- UMLS CUI [1]
- C0031117
Description
Dyslipidaemia
Data type
integer
Alias
- UMLS CUI [1]
- C0242339
Description
Diabetic foot ulcer
Data type
integer
Alias
- UMLS CUI [1,1]
- C0085119
- UMLS CUI [1,2]
- C0206172
Description
Proteinuria/ nephropathy
Data type
integer
Alias
- UMLS CUI [1]
- C0033687
- UMLS CUI [2]
- C0011881
Description
Microalbuminuria
Data type
integer
Alias
- UMLS CUI [1]
- C0730345
Description
Chronic renal Insufficiency / chronic renal failure
Data type
integer
Alias
- UMLS CUI [1]
- C0022661
- UMLS CUI [2]
- C0403447
Description
Other Medical Conditions of Interest
Alias
- UMLS CUI-1
- C0012634
- UMLS CUI-2
- C0009488
- UMLS CUI-3
- C0262926
Description
Anaemia
Data type
integer
Alias
- UMLS CUI [1]
- C0002871
Description
Select status for each condition entered.
Data type
text
Alias
- UMLS CUI [1]
- C0012634
Description
Select status for each condition entered.
Data type
integer
Alias
- UMLS CUI [1]
- C3176928
Description
Central Laboratory
Alias
- UMLS CUI-1
- C1880016
- UMLS CUI-2
- C0022885
Description
Pre-Study Diabetes Treatment
Alias
- UMLS CUI-1
- C0087111
- UMLS CUI-2
- C0013227
- UMLS CUI-3
- C0011849
Description
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Description
Inclusion Criteria
Alias
- UMLS CUI-1
- C1512693
- UMLS CUI-2
- C1516637
Description
I f 'No', check the boxes corresponding to any of the inclusion criteria the subject failed
Data type
boolean
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1516637
Description
inclusion criteria the subject failed
Data type
integer
Alias
- UMLS CUI [1,1]
- C1512693
- UMLS CUI [1,2]
- C1516637
- UMLS CUI [1,3]
- C0231175
Description
exception(s) Inclusion Criteria
Data type
text
Alias
- UMLS CUI [1,1]
- C1705847
- UMLS CUI [1,2]
- C1512693
- UMLS CUI [1,3]
- C1516637
Description
Exclusion Criteria
Alias
- UMLS CUI-1
- C0680251
- UMLS CUI-2
- C1516637
Description
I f 'Yes', check all boxes corresponding to the exclusion criteria that disqualified the subject from entry.
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1516637
Description
exclusion criteria failed
Data type
integer
Alias
- UMLS CUI [1,1]
- C0680251
- UMLS CUI [1,2]
- C1516637
Description
exception(s) Exclusion Criteria
Data type
text
Alias
- UMLS CUI [1,1]
- C1705847
- UMLS CUI [1,2]
- C0680251
Description
Concomitant Medications Prompt
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0013227
Description
Subject Continuation
Alias
- UMLS CUI-1
- C0805733
- UMLS CUI-2
- C2348568
Similar models
Screening - Visit 2
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0277814 (UMLS CUI [1,2])
C0007222 (UMLS CUI-2)
C0878544 (UMLS CUI [1,2])
C0262926 (UMLS CUI-2)
C0206172 (UMLS CUI [1,2])
C0011881 (UMLS CUI [2])
C0403447 (UMLS CUI [2])
C0009488 (UMLS CUI-2)
C0262926 (UMLS CUI-3)
C0200354 (UMLS CUI [2])
C0013227 (UMLS CUI-2)
C0011849 (UMLS CUI-3)
C0011849 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C1512693 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,3])
C1516637 (UMLS CUI [1,2])
C1516637 (UMLS CUI [1,2])
C0680251 (UMLS CUI [1,2])
C0013227 (UMLS CUI-2)
C2169461 (UMLS CUI [1,2])